Impaired Preoperative Nutritional Status as a Risk Factor for Postoperative Clinical Outcome (PreopBIA)

Impaired Preoperative Nutritional Status as a Risk Factor for Postoperative Clinical Outcome (PreopBIA)

The aim of this retrospective observational study is to determine the impact of preoperative nutritional status on postoperative outcome. Elective surgical patients were screened with Bio-Impedance-Analysis, Malnutritional Universal Screening Tool, and other variables for body composition. Outcome parameters were collected by patient chart review.

Study Overview

• Status: Completed
• Conditions: Nutritional Status

• Study Type: Observational
• Enrollment (Actual): 400

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 10117
    • Department of Anesthesiology and Operative Intensive Care Medicine Campus Charité Mitte, Charite University,

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Elective surgical patients

Description

Inclusion Criteria:

1. Elective surgical intervention
2. Patients must be 18 years or older
3. Ambulation
4. ASA-Score I-IV
5. bioelectrical impedance analysis to determine the phase angle

Exclusion Criteria:

1. Emergency surgery
2. Pregnancy
3. ASA Score V-VI
4. Amputated limbs
5. Pacemaker and defibrillators
6. Cerebrovascular events
7. Tattoos on the electrode locations

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Elective surgical patients; Elective surgical patients in the Charité University Berlin Campus Charité Mitte

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Phase-angle	preoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
body weight		preoperative
body mass index (BMI)		preoperative
preoperative weight loss		3 month weight loss before operation
hip/waist ratio		preoperative
Malnutrition Universal Screening Tool (MUST)	The MUST is recommended by ESPEN as the preferred screening tool for patients in the community (Kondrup J et al., Clinical Nutrition 2003; 22: 415-421)	preoperative
postoperative complications	The Clavien-Dindo Classification of Surgical Complications (Dindo D., Demartines N., Clavien P.A.; Ann Surg. 2004; 244: 931-937)	postoperative
Length of hospital stay		participants will be followed for the duration of hospital stay

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany
• Investigators: Study Director: Claudia Spies, MD Prof., Department of Anesthesiology and Operative Intensive Care Medicine Campus Charité Mitte, Charite University, Berlin, Germany

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (Actual): November 1, 2010
• Study Completion (Actual): July 1, 2012

Study Registration Dates

• First Submitted: December 14, 2011
• First Submitted That Met QC Criteria: December 14, 2011
• First Posted (Estimate): December 15, 2011

Study Record Updates

• Last Update Posted (Estimate): January 23, 2017
• Last Update Submitted That Met QC Criteria: January 20, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: Post-operative outcome; Malnutrition; Bioelectrical impedance analysis; Phase angle; MUST; Clavien Dindo classification
• Other Study ID Numbers: PreopBIA